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Diabetic Macular Edema

92
Pipeline Programs
30
Companies
50
Clinical Trials
3 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
20
11
22
1
16
22
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
2292%
Small Molecule
28%
+ 122 programs with unclassified modality

On Market (4)

Approved therapies currently available

AbbVie
OZURDEXApproved
dexamethasone
AbbVie
Corticosteroid [EPC]intravitreal2009
2M Part D
Novartis
BEOVUApproved
brolucizumab
Novartis
intravitreal2019
602K Part D
Novartis
CIMERLIApproved
ranibizumab-eqrn
Novartis
Vascular Endothelial Growth Factor Inhibitor [EPC]injection2022
82K Part D
AbbVie
AEROSEB-DEXApproved
dexamethasone
AbbVie
topical

Competitive Landscape

55 companies ranked by most advanced pipeline stage

Sandoz
SandozAustria - Kundl
23 programs
1
4
10
5
RanibizumabPhase 4Monoclonal Antibody1 trial
RanibizumabPhase 4Monoclonal Antibody1 trial
brolucizumabPhase 4Monoclonal Antibody1 trial
intravitreal injection of Brolucizumab 6 mg in study eyePhase 41 trial
ranibizumabPhase 4Monoclonal Antibody1 trial
+18 more programs
Active Trials
NCT05526729Completed222Est. Jun 2024
NCT02325271Completed40Est. Jan 2016
NCT02329132Completed30Est. Feb 2018
+20 more trials
AbbVie
AbbVieNORTH CHICAGO, IL
21 programs
1
4
2
10
BevacizumabPhase 4Monoclonal Antibody2 trials
Dexamethasone Intravitreal ImplantPhase 41 trial
Dexamethasone implantPhase 41 trial
Dexamethasone intravitreal implantPhase 41 trial
Dexamethasone intravitreal implantPhase 41 trial
+16 more programs
Active Trials
NCT03889444Completed141Est. Jun 2019
NCT06332690Unknown50Est. Dec 2025
NCT03003416Completed115Est. Dec 2018
+17 more trials
Novartis
NovartisBASEL, Switzerland
6 programs
1
BeovuN/A
Frequent blood and urine sampling and blood pressure measurementN/A
LKA651PHASE_2
BEOVU(Brolucizumab)PHASE_3Monoclonal Antibody
Labeled regime armPHASE_3
+1 more programs
Innovation Pharmaceuticals
4 programs
1
1
IlUVIENPhase 41 trial
CU06-1004Phase 21 trial
Bevacizumab InjectionN/A1 trial
OzurdexN/A1 trial
Active Trials
NCT04067856Withdrawn0Est. Jan 2021
NCT02121197Completed321Est. Jan 2016
NCT05573100Completed67Est. Jun 2023
+1 more trials
ANI Pharmaceuticals
ANI PharmaceuticalsPRINCETON, NJ
2 programs
2
Iluvien 0.19 MG Drug ImplantPhase 41 trial
fluocinolone acetonidePhase 45 trials
Active Trials
NCT04469595Active Not Recruiting300Est. Dec 2024
NCT06539481Recruiting25Est. Oct 2028
NCT05322070Active Not Recruiting125Est. Nov 2025
+3 more trials
RemeGen
2 programs
1
1
RC-28EPhase 31 trial
intravitreal injection of RC28-EPhase 21 trial
Active Trials
NCT04782115Completed156Est. Jul 2023
NCT05885503Recruiting316Est. Jun 2026
Kodiak Sciences
Kodiak SciencesCA - Palo Alto
2 programs
2
KSI-301Phase 31 trial
KSI-301Phase 31 trial
Active Trials
NCT04603937Terminated459Est. Aug 2023
NCT04611152Terminated460Est. Aug 2023
Alvotech
AlvotechLUXEMBOURG, Luxembourg
1 program
1
aflibercept HD biosimilarPhase 31 trial
Active Trials
NCT07489131Recruiting256Est. Jan 2028
Bausch Health
Bausch HealthQUEBEC, Quebec, Canada
3 programs
1
1
1
fluocinolone acetonidePhase 2/31 trial
0.59 mg fluocinolone acetonide intravitreal implantPhase 21 trial
Bromfenac ophthalmic solutionPhase 11 trial
Active Trials
NCT00491166Unknown10
NCT00576459Completed40Est. Jul 2006
NCT00502541Completed196Est. Sep 2006
BioTherapeutics Inc
BioTherapeutics IncVA - Blacksburg
3 programs
1
1
1
AG-73305Phase 21 trial
MTP-131Phase 1/21 trial
EBI-031Phase 11 trial
Active Trials
NCT02842541Withdrawn0Est. Feb 2018
NCT02314299Completed20Est. Jun 2015
NCT05301751Completed25Est. Dec 2023
Allegro Ophthalmics
1
2
Luminate 1.0mgPhase 21 trial
risuteganibPhase 2Small Molecule1 trial
ALG-1001Phase 1/21 trial
Active Trials
NCT01482871Withdrawn0Est. Nov 2011
NCT02348918Completed218Est. Jun 2017
NCT03626636Completed42Est. Apr 2019
Adverum Biotechnologies
1
6E11 vg/eye of ADVM-022Phase 21 trial
ADVM-022N/A1 trial
Active Trials
NCT05607810Active Not Recruiting22Est. Apr 2026
NCT04418427Completed36Est. Jun 2023
Curacle
2 programs
1
1
CU06-1004Phase 2
CU06-1004, Single dosePhase 11 trial
Active Trials
NCT04795037Completed81Est. Jun 2022
Clearside Biomedical
Clearside BiomedicalGA - Alpharetta
2 programs
1
1
IVT afliberceptPhase 21 trial
IVT AfliberceptPhase 1/21 trial
Active Trials
NCT02949024Completed20Est. Oct 2017
NCT03126786Completed71Est. Apr 2018
Allgenesis Biotherapeutics
1
AG-73305Phase 2
Aviceda Therapeutics
Aviceda TherapeuticsMA - Cambridge
1 program
1
AVD-104Phase 22 trials
Active Trials
NCT06181227Terminated21Est. Apr 2024
NCT05839041Active Not Recruiting300Est. Oct 2026
Abbott
AbbottABBOTT PARK, IL
1 program
1
Choline FenofibratePhase 21 trial
Active Trials
NCT00683176Completed110Est. Mar 2011
Regenxbio
1 program
1
RGX-314 Dose 1Phase 21 trial
Active Trials
NCT06942520Recruiting18Est. Dec 2027
Medica Corp
Medica CorpMA - Bedford
1 program
1
Ranibizumab 0.05mgPhase 21 trial
Active Trials
NCT01112085Completed72Est. Jun 2014
Frontera Therapeutics
1
1
FT-003Phase 1/21 trial
FT-003Phase 11 trial
Active Trials
NCT05916391Recruiting18Est. May 2028
NCT06492876Recruiting78Est. Nov 2028
Biocorp
2 programs
1
1
2.5mg of BAT5906Phase 1/21 trial
THN391 MADPhase 11 trial
Active Trials
NCT06701721Recruiting21Est. Feb 2026
NCT04772105Completed60Est. Nov 2023
Bio-Thera Solutions
1
2.5mg of BAT5906Phase 1/2
Opthea
1 program
1
AfliberceptPhase 1/21 trial
Active Trials
NCT03397264Completed153Est. Jun 2020
Eclipse Life Sciences
1
EC-104 high dosePhase 1/21 trial
Active Trials
NCT06536491Recruiting75Est. Dec 2025
Exonate
1 program
1
EXN407Phase 1/21 trial
Active Trials
NCT04565756Completed48Est. Nov 2022
OcuTerra
1 program
1
SF0166 Topical Ophthalmic SolutionPhase 1/21 trial
Active Trials
NCT02914613Completed44Est. May 2017
Sanwa Kagaku Kenkyusho
1
dexamethasonePhase 1/21 trial
Active Trials
NCT00308542Completed
Genentech
8 programs
1
RO7497372Phase 11 trial
Identifying Patients With Unrecognized Treatable Diabetic Macular EdemaN/A1 trial
RO7823653PHASE_11 trial
0.3 mg ranibizumabPHASE_1_2Monoclonal Antibody1 trial
RanibizumabPHASE_1_2Monoclonal Antibody1 trial
+3 more programs
Active Trials
NCT01934920Unknown500Est. May 2019
NCT07425522Recruiting93Est. Nov 2028
NCT01552408Completed29Est. May 2017
+5 more trials
Inflammasome Therapeutics
2 programs
2
K8Phase 11 trial
Kamuvudine-9Phase 11 trial
Active Trials
NCT05699759Completed1Est. Jun 2024
NCT06781255Terminated1Est. Feb 2026
Askgene Pharma
1
ASKG712Phase 12 trials
Active Trials
NCT05940428Active Not Recruiting26Est. Dec 2025
NCT05456828Active Not Recruiting56Est. Dec 2025

+25 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
RocheFaricimab
Sandozbrolucizumab
ANI Pharmaceuticalsfluocinolone acetonide
Sandozintravitreal injection of Brolucizumab 6 mg in study eye
AbbVieOzurdex
ANI Pharmaceuticalsfluocinolone acetonide
GenentechFaricimab
ANI PharmaceuticalsIluvien 0.19 MG Drug Implant
AbbVieDexamethasone implant
AbbVieDexamethasone Intravitreal Implant
AbbVieOzurdex Drug Implant Product
SantenAflibercept Injection [Eylea]
AbbVieBevacizumab
RegeneronIntravitreal Aflibercept
AbbVieDexamethasone intravitreal implant

Showing 15 of 49 trials with date data

Clinical Trials (50)

Total enrollment: 11,180 patients across 50 trials

Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material

Start: Apr 2026Est. completion: Oct 2028100 patients
Phase 4Not Yet Recruiting
NCT05959304Sandozbrolucizumab

Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.

Start: Dec 2024Est. completion: Nov 202566 patients
Phase 4Completed
NCT06539481ANI Pharmaceuticalsfluocinolone acetonide

Open Label Trial Studying the Safety and Effectiveness of ILUVIEN® (190μg) in Children and Adolescents, Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye.

Start: Aug 2024Est. completion: Oct 202825 patients
Phase 4Recruiting
NCT06498050Sandozintravitreal injection of Brolucizumab 6 mg in study eye

Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema

Start: Jul 2024Est. completion: Jul 202552 patients
Phase 4Active Not Recruiting

Compare the Efficacy of VItrectomy Combined With DExamethasone Implant Versus With Aflibercept in DME Patients Diagnosed by Intraoperative OCT (the VIDEO Study): Study Protocol for a Randomized Controlled Trial

Start: Oct 2023Est. completion: Apr 202564 patients
Phase 4Unknown
NCT05322070ANI Pharmaceuticalsfluocinolone acetonide

Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis

Start: Jun 2022Est. completion: Nov 2025125 patients
Phase 4Active Not Recruiting

A Study to Investigate Faricimab Treatment Response in Treatment-Naive, Underrepresented Patients With Diabetic Macular Edema

Start: Feb 2022Est. completion: Jan 2027218 patients
Phase 4Active Not Recruiting
NCT04469595ANI PharmaceuticalsIluvien 0.19 MG Drug Implant

A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

Start: Aug 2020Est. completion: Dec 2024300 patients
Phase 4Active Not Recruiting
NCT04411693AbbVieDexamethasone implant

Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema

Start: Apr 2020Est. completion: Jan 202423 patients
Phase 4Completed
NCT03953807AbbVieDexamethasone Intravitreal Implant

A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated

Start: Sep 2019Est. completion: Jul 202282 patients
Phase 4Completed
NCT04038125AbbVieOzurdex Drug Implant Product

Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME

Start: Aug 2019Est. completion: Aug 202120 patients
Phase 4Unknown
NCT03197480SantenAflibercept Injection [Eylea]

Diabetic Macular Edema Asian Response (DEAR) Study: Biomarkers for Response to Aflibercept in Asian Patients With Center Involving DME

Start: Apr 2019Est. completion: Mar 202136 patients
Phase 4Unknown

Steroid vs. Anti-vascular Endothelial Growth Factor for Diabetic Macular Edema Prior to Phacoemulsification

Start: Nov 2018Est. completion: Mar 202416 patients
Phase 4Completed
NCT03059277RegeneronIntravitreal Aflibercept

Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab

Start: Jun 2018Est. completion: Sep 20200
Phase 4Withdrawn
NCT04619303AbbVieDexamethasone intravitreal implant

Intravitreal Dexamethasone vs Bevacizumab in Aboriginal People With DMO

Start: Feb 2017Est. completion: Feb 202059 patients
Phase 4Completed

Combination OZURDEX® & LUCENTIS® vs. OZURDEX® Monotherapy in Incomplete-Responders With Diabetic Macular Edema

Start: Nov 2015Est. completion: Dec 20165 patients
Phase 4Terminated
NCT02471651AbbVieDexamethasone intravitreal implant

Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema

Start: Jun 2015Est. completion: Oct 201840 patients
Phase 4Completed

A Pilot Study on the Effect and Safety of Iluvien® in Chronic Diabetic Macular Edema Patients

Start: Oct 2014Est. completion: Dec 201612 patients
Phase 4Completed

Combination of Standard Lucentis Therapy With Micropulse Diode Laser for the Treatment of Diabetic Macular Edema

Start: Apr 2014Est. completion: Dec 201725 patients
Phase 4Unknown

Retinal Ganglion Cell Function After Intravitreous Ranibizumab in Patients With Diabetic Macular Edema

Start: Mar 2014Est. completion: Jul 20150
Phase 4Withdrawn

Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

Start: Jan 2014Est. completion: Aug 201545 patients
Phase 4Completed

Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)

Start: Jul 2012Est. completion: Feb 201730 patients
Phase 4Completed

Ranibizumab "Treat and Extend" in Diabetic Macular Edma

Start: Jan 2011Est. completion: Nov 20127 patients
Phase 4Completed

A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer

Start: May 2026Est. completion: May 2029700 patients
Phase 3Not Yet Recruiting
NCT07489131Alvotechaflibercept HD biosimilar

Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in Participants With Diabetic Macular Edema

Start: Apr 2026Est. completion: Jan 2028256 patients
Phase 3Recruiting
NCT06172257OculisDexamethasone ophthalmic suspension

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 2)

Start: Mar 2024Est. completion: Apr 2026401 patients
Phase 3Completed

Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema

Start: Jun 2023Est. completion: Jun 2026316 patients
Phase 3Recruiting

A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

Start: Sep 2020Est. completion: Aug 2023460 patients
Phase 3Terminated

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)

Start: Sep 2020Est. completion: Aug 2023459 patients
Phase 3Terminated
NCT04058067SandozBrolucizumab

To Compare Brolucizumab to Aflibercept in Chinese Patients With Visual Impairment Due to Diabetic Macular Edema

Start: Aug 2019Est. completion: Jan 2023266 patients
Phase 3Completed
NCT03917472SandozBrolucizumab

Efficacy and Safety of Brolucizumab vs Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Start: Jul 2019Est. completion: Mar 2021517 patients
Phase 3Completed
NCT03481660SandozBrolucizumab

A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Start: Jul 2018Est. completion: Jun 2021360 patients
Phase 3Completed
NCT03481634SandozBrolucizumab

Study of Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

Start: Jul 2018Est. completion: Oct 2021566 patients
Phase 3Completed
NCT02262260SandozLabeled regime arm

Compare Safety/Efficacy of Labeled vs Wait-Extend Regimen of Lucentis in Turkish Patients With VI Due to DME

Start: Dec 2014Est. completion: Sep 201787 patients
Phase 3Completed

A 12-month, Randomized, Efficacy and Safety Study of 0.5 mg Ranibizumab vs Laser in Chinese Diabetic Macular Edema (DME) Patients

Start: Nov 2014Est. completion: Jan 2017384 patients
Phase 3Completed

Treatment for CI-DME in Eyes With Very Good VA Study

Start: Oct 2013Est. completion: Sep 2018702 patients
Phase 3Completed
NCT01304706ANI Pharmaceuticalsfluocinolone acetonide

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

Start: Apr 2011120 patients
Phase 3Completed

Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus

Start: Sep 2010Est. completion: Apr 2013373 patients
Phase 3Completed

Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)

Start: Jul 2010Est. completion: Mar 2013241 patients
Phase 3Completed

Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema

Start: Sep 2009Est. completion: Aug 2011396 patients
Phase 3Completed

A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study

Start: May 2008Est. completion: Jan 2012345 patients
Phase 3Completed
NCT00344968ANI Pharmaceuticalsfluocinolone acetonide

Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema

Start: Sep 2007Est. completion: Dec 2010956 patients
Phase 3Completed
NCT00490815ANI Pharmaceuticalsfluocinolone acetonide

Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

Start: Aug 2007Est. completion: Apr 201137 patients
Phase 3Completed
NCT00168337AbbVieDexamethasone

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Start: May 2005Est. completion: May 2012554 patients
Phase 3Completed
NCT00168389AbbVieDexamethasone

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Start: Feb 2005Est. completion: Jun 2012494 patients
Phase 3Completed
NCT01411254SantenBetamethasone Microsphere

Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)

Phase 2/3Completed
NCT05066997OculisDexamethasone ophthalmic suspension

A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)

Start: Oct 2021Est. completion: Apr 2026552 patients
Phase 2/3Active Not Recruiting
NCT01355692LumenisNd: YLF laser treatment

Evaluation of the Effects of Selective Photocoagulation for the Treatment of Diabetic Macular Edema

Start: Dec 2009Est. completion: Jul 201532 patients
Phase 2/3Completed
NCT00502541Bausch Healthfluocinolone acetonide

Efficacy of Fluocinolone Acetonide Intravitreal Implant in Diabetic Macular Edema

Start: Sep 2001Est. completion: Sep 2006196 patients
Phase 2/3Completed

A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients

Start: Nov 2025Est. completion: Mar 202760 patients
Phase 2Not Yet Recruiting

Related Jobs

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

16 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 11,180 patients
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.